- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606073
The Influence of Different Concentrations of Glucose in Culture Media on Fertilization and Embryo Quality
January 21, 2008 updated by: Hillel Yaffe Medical Center
The Influence of Different Concentrations of Glucose in Culture Media(i.e: ISM1 vs. IVF) on Fertilization and Embryo Quality
The aim of this study is to examine whether incubation of human oocytes until pronuclear stage, in different culture media containing high and low concentrations of glucose affect fertilization differently, not only in standard IVF cycles, but also after intracytoplasmatic sperm injection.In addition, we wish to determine whether exposure of oocytes to different concentrations of glucose until pronuclear stage has further effect on embryo quality and development until the blastocyst stage.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing IVF treatment in our clinic during study period
Exclusion Criteria:
- Females older than 40 years
- Patients with less than 6 retrieved oocytes
- Male patients older than 50 years old
- Patients after testis biopsies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: I
IVF Procedure-IVF Medium
|
Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection.
Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance.
After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only.
The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.
|
|
Active Comparator: II
IVF Procedure - ISM1 Medium
|
Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection.
Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance.
After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only.
The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.
|
|
Active Comparator: III
ICSI Procedure - IVF Medium
|
Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection.
Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance.
After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only.
The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.
|
|
Active Comparator: IV
ICSI Procedure - ISM1 Medium
|
Sibling oocytes will be equally divided and incubated separately in different 4-well culture dishes containing either IVF medium or ISM1 Medium and while ICSI will be returned to the same culture dish following injection.
Fertilization assessment will be performed approximately after 15-20 hours for standard IVF and 12-18 hours post ICSI performance.
After assessment, fertilized oocytes from different culture media will be transferred separately into fresh culture dishes containing ISM1 medium only.
The zygotes will be incubated until embryo transfer on day 2 or 3. Embryo quality will be assessed according to the morphology of blastomeres as well as it's developmental stage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fertilization rate and embryo quality
Time Frame: 6 days
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Anticipated)
August 1, 2009
Study Registration Dates
First Submitted
January 21, 2008
First Submitted That Met QC Criteria
January 21, 2008
First Posted (Estimate)
February 1, 2008
Study Record Updates
Last Update Posted (Estimate)
February 1, 2008
Last Update Submitted That Met QC Criteria
January 21, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- HYMC IRB#31/2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.